评估一种新型血管内“血流隔离器”支架治疗颅内动脉瘤的安全性和技术有效性：日本首例人体单臂多中心临床试验研究方案。
Evaluating the safety and technical effectiveness of a newly developed intravascular 'flow isolator' stent for the treatment of intracranial aneurysms: study protocol for a first-in-human single-arm multiple-site clinical trial in Japan.
机构信息
Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
出版信息
BMJ Open. 2019 May 9;9(5):e020966. doi: 10.1136/bmjopen-2017-020966.
INTRODUCTION
Wide-neck or large intracranial aneurysms are difficult to cure by conventional surgical or endovascular procedures. A flow diverter (FD) is an implantable, stent-like, fine-mesh medical device for the treatment of intracranial aneurysms. Although endovascular treatment with FDs is becoming a routine first-line option, a systematic review noted the heterogeneity and publication biases of the clinical studies for FDs. We have developed a new honeycomb microporous covered stent (NCVC-CS1) as a 'flow isolator' for the endovascular treatment of intracranial aneurysms.
METHODS AND ANALYSIS
We planned the NCVC-CS1_UAN as a first-in-human study to evaluate the safety and technical effectiveness of the NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms that are difficult to cure by conventional surgical or endovascular procedures. The study is a multicentre, open-label, uncontrolled, exploratory, medical device, investigator-initiated clinical study. The primary safety endpoint of this study is any stroke or death related to the procedure within 180 days, while for efficacy, the endpoint is complete obliteration of the target aneurysm and patency of the target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure.
ETHICS AND DISSEMINATION
Full ethics approval of institutional review boards was obtained at all participating sites. A clinical trial notification as a new medical device was accepted by the Japanese regulatory agency before it started. The study should be followed by a pivotal study to obtain satisfactory data for an application for marketing approval. The main results of this study will be submitted for publication in a peer-reviewed journal. The planned subject number for this study is 12.
TRIAL REGISTRATION NUMBER
NCT02907229.
简介
宽颈或大型颅内动脉瘤难以通过传统的手术或血管内治疗。血流导向装置（FD）是一种可植入的、支架样的、细网医疗设备，用于治疗颅内动脉瘤。尽管使用 FD 的血管内治疗正成为常规的一线选择，但系统评价指出了 FD 的临床研究存在异质性和发表偏倚。我们开发了一种新型的蜂巢微孔覆膜支架（NCVC-CS1）作为一种“血流隔离器”，用于颅内动脉瘤的血管内治疗。
方法和分析
我们计划进行 NCVC-CS1_UAN 作为首例人体研究，以评估新型蜂巢微孔覆膜支架 NCVC-CS1 治疗常规手术或血管内治疗难以治愈的颅内动脉瘤的安全性和技术有效性。该研究是一项多中心、开放标签、非对照、探索性、医疗器械、研究者发起的临床研究。该研究的主要安全性终点是 180 天内与该手术相关的任何中风或死亡，而在疗效方面，终点是目标动脉瘤完全闭塞和目标血管通畅（狭窄小于 50%），通过术后 180 天的血管造影确认。
伦理和传播
所有参与站点均获得了机构审查委员会的全面伦理批准。在开始前，日本监管机构接受了作为新医疗器械的临床试验通知。该研究应随后进行一项关键性研究，以获得用于申请上市许可的满意数据。该研究的主要结果将提交给同行评议期刊发表。该研究计划的受试者数量为 12 人。
试验注册号
NCT02907229。
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